Light based therapy devices and methods

ABSTRACT

The present invention relates to a light therapy device article of manufacture, system and method for providing light is delivered to the skin by means of one or more optical fibers in therapeutic dosages from light source in wavelengths of 614-624 nm, 668-684 nm, 751-772 nm, and 813-846 nm. The light source may be comprised from one or more light emitting diodes LED disposed on a flexible printed circuit board (PCB) and ferrule adapter assembly configured to deliver light to the skin directly of the patient from the light source disposed on the PCB adjacent a scalp surface. A control circuit operably connected to the PCB is adapted to provide energy to one or more zones of LEDs to address hair loss treatment regimen including splotchy balding, receding hairline balding, crown balding and total scalp surface therapy. Accordingly, a portable, cordless, hands-free light therapy device may configured as a headdress to be worn by the patient to minimize the negative psychological association of hair loss, while still providing effective hair growth treatment at an affordable price.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/677,840 filed Aug. 15, 2017, the entirety of which is incorporated byreference herein.

BACKGROUND OF THE INVENTION

The present invention relates to designs, systems and methods of a lighttherapy device.

The concept of using light energy to treat human tissues has emerged inthe last few decades. Radiation, UV, and broad spectrum light have allbeen employed therapeutically and efficaciously, enjoying wideacceptance in the medical community. One version of this, called LowLevel Light Therapy (LLLT), uses a wide variety of wavelengths in thevisible and near-infrared spectrum to generate a tissue response in aprocess that has become known as photobiomodulation. The potential listof applications for LLLT is enormous; everything from dental treatmentsto pain control and accelerated wound healing has been studied withpromising results. Given the low incidence of side effects, ability totarget specific tissues, and the relative ease of treatment, patient andphysician acceptance and adoption of these technologies is justifiablygrowing.

The method of delivery has been problematic, however. Due to itscoherent, single wavelength output and directionality, the laser diodeis a commonly used light source, allowing practitioners to easily directthe beam to the target. Another potential source, the light emittingdiode (LED), can also be used to generate light in a specific band ofwavelengths, but with a much broader emission pattern. For completeness,we note that it is possible to generate either narrow or broad spectralranges with a white light source and a filter. It has yet to beestablished whether narrow or broader emission spectra or coherent orincoherent light is more effective to induce photobiomodulation. Theissue with all of the light sources is that human tissue, such as skin,can be highly reflecting. Furthermore, the presence of hair on the skincan cause significant absorption of the light intended for the skin.These two effects make it difficult to precisely control dosing duringtherapeutic applications. Since light can be scattered, absorbed,transmitted, or reflected, the light applied during certain LLLTapplications should either be on the surface of the target, or be veryclose to be absorbed.

One major application of LLLT is to treat hair loss. Also known asalopecia, hair loss can be found in every country and has unfavorablesocial connotations in all cultures worldwide. Male pattern hair loss,or androgenetic alopecia, accounts for 95% of alopecia in males, with70% of American men experiencing some form of hair loss by age 35.Female hair loss, while it is often more complex in etiology, affects asimilarly large portion of women worldwide, with some estimates rangingfrom 1:4 in the United States (25%), to over 80% of women past the ageof 60 (when hormones like estrogen drop). There is no cure for male orfemale pattern hair loss.

Unfortunately, the list of proven medical therapies that will help eventhe most common causes of hair loss is a short one. In the UnitedStates, men and women can use minoxidil (2% and 5%) in both liquid andfoam forms, but this medication requires twice daily application and isconsidered distasteful and inconvenient by many. Men have the additionalbenefit of being able to use the daily oral medication finasteride,which can be extremely effective. There is a widespread misunderstandingregarding its side effect profile, however, since it can transientlyaffect libido (2.1-3.8% incidence), which hinders its adoption. Surgicalhair restoration is effective, but it is expensive, and, as a result,unavailable to many patients.

Photobiomodulation is a recent addition to the existing FDA-approvedhair loss armamentarium. LLLT in the wavelengths of 614-624 nm, 668-684nm, 751-772 nm, and 813-846 nm, has been proven to reduce inflammationin the scalp, stimulate the release of growth factors in the hairfollicle, up-regulate the production of ATP (the energy source for thecell), and increase oxygen levels and blood flow via a vasodilatoryeffect. Devices of all sorts including combs, helmets, handheld“massager-type” units, and hoods all have gained 510K clearance to besold with the claim that they grow hair.

Currently, none of the published studies of these devices conforms tothe wavelengths of light known to produce increased cellular activity inthe hair follicle, and few of them even produce light within these knownwavelength ranges. Furthermore, many light therapy devices deliver lightto the skin from a distance or from above the hair. Such light may beabsorbed by the presence of hair follicles, thereby limiting theavailable dose. Even if hair is not initially present, if hair growthoccurs during the use of such LLLT devices, the light therapy processwill be self-limiting. For these reasons, many existing LLLT devicesolutions for hair growth are sub-optimal at best, and ineffective atworst. Also, dosing time and frequency recommendations vary amongdevices, leading to sub-optimal treatments. Another concern withconventional devices arises when the device causes heating of thetargeted region of the scalp, excessive heating can decrease the resultsof the therapy, leading to the potential for sub-optimal dosing. Basedon the above, there is room for improved systems, devices, and methodsfor application of LLLT therapy.

BRIEF SUMMARY OF THE INVENTION

A variation of the improved systems, methods, and devices for providingLLLT devices. In one aspect, such devices are suited for hair growth byapplying light delivery to the skin using one or more illuminationsources. For example, the illumination source can comprise coherentlight (e.g., laser), incoherent (e.g. LED, white light plus filter),filtered light, or a combination thereof. The illumination provided bythe illumination source can be of a wavelength or wavelength range thatis of beneficial and therapeutic value. The illumination source cancomprise a source that transmits light from another location (e.g., anoptical fiber) that generates the illumination, or the illuminationsource can also directly generate the illumination (such as an LEDcomponent). In some variations, the illumination source delivers thelight to the treatment area via direct contact with the skin. In othervariations, the illumination source delivers light to the treatment areajust above the skin. In certain applications, positioning of theillumination source close to the tissue being treated such that thelight delivery bypasses the interference that even short hair shaftsabove the skin create. Such close delivery allows for predicable andknown dosing intensity and distribution, which enables standardizeddosing. In certain variations of the devices and methods, it isdesirable to prevent heat from increasing at the treated region.Therefore, the heat generated by the light sources can be kept away fromthe skin and to avoid a significant increase the temperature of theskin. A cooling scheme can also be used to either preserve the outputpower and efficiency of the light source itself or to cool the treatedtissue.

Variations of the device and system include illumination sources thatare shaped for patient comfort and/or to distribute the light around thedelivery or contact point. In additional variations, a projectingelement that includes or carries the illumination source is actuated soas to allow conformal contact with the skin. In an exemplary embodiment,an array of such projection elements having illumination sources areused to illuminate a substantial area of skin, such as the scalp. Anadvanced passive cooling scheme is used to preserve the output power andefficiency of the light sources. Advantageously, the present inventiondelivers light directly to the skin bypassing interference from hairfollicles, thereby allowing for a known dosing intensity anddistribution. The configurations described herein can provide animprovement in light delivery to the targeted region—one that reducesloss of energy to undesired absorption and reflection and that ensuresmaximum absorption by the target tissue, thereby enabling standardizeddosing. Variations of the devices described herein can also allowdelivery of light at or very close to the skin/scalp, which allowsbypassing the interference that even short hair shafts above the skincreate, and minimizing the effect of reflection. Second, it woulddeliver light in one of the four optimum wavelength ranges.

Variations of the device also allow for a hands-free, cordless, andportable, with an interactive feedback component that allows a patientto monitor their progress, further improving adherence with thetreatment regimen. Such variations also time the treatments and helppatients manage dosing frequency with a minimal amount of externalvisibility. Cell proliferation (i.e. growth of hair) is optimized withlow doses over longer periods of time. So, the present LLLT deviceallows for convenient and frequent dosing (at least 2-3 times per week,if not daily).

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

FIG. 1. Illustrates a perspective view of light therapy device for thescalp.

FIG. 2. Illustrates a cross-section, perspective view of light therapydevice for the scalp with flexible PCB.

FIG. 3. Illustrates a close-up, cross-section, perspective view offlexible PCB, illumination assembly and dome alignment.

FIG. 4. Illustrates a perspective view of flattened flexible PCB anddome prior to assembly.

FIG. 5. Illustrates a close-up, cut-away, perspective view of flexiblePCB, illumination assembly and dome alignment.

FIG. 6. Illustrates a perspective, cutaway view of alternativeembodiment of light therapy device for the scalp.

FIG. 7. Illustrates a close-up, cross-section, perspective view of theillumination assembly and dome alignment.

FIG. 8. Illustrates a close-up, cut-away, perspective view of rigid PCB,ferrule, and alignment structure.

DETAILED DESCRIPTION OF THE INVENTION

For a better understanding of the present invention, reference will bemade to the following Description of the Embodiments, which is to beread in association with the accompanying drawings, which areincorporated in and constitute a part of this specification, showcertain aspects of the subject matter disclosed herein and, togetherwith the description, help explain some of the principles associatedwith the disclosed implementations.

The terms “a” or “an”, as used herein, are defined as one or as morethan one. The term “plurality”, as used herein, is defined as two or asmore than two. The term “another”, as used herein, is defined as atleast a second or more. The terms “including” and/or “having”, as usedherein, are defined as comprising. (i.e., open language). The term“coupled”, as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

Reference throughout this document to “some embodiments”, “oneembodiment”, “certain embodiments”, and “an embodiment” or similar termsmeans that a particular feature, structure, or characteristic describedin connection with the embodiment is included in at least one embodimentof the present invention. Thus, the appearances of such phrases or invarious places throughout this specification are not necessarily allreferring to the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments without limitation.

The term “or” as used herein is to be interpreted as an inclusive ormeaning any one or any combination. Therefore, “A, B or C” means any ofthe following: “A; B; C; A and B; A and C; B and C; A, B and C”. Anexception to this definition will occur only when a combination ofelements, functions, steps or acts are in some way inherently mutuallyexclusive.

FIG. 1 presents a perspective view of an exemplary light therapy devicefor the scalp. The exemplary light therapy device discussed below isintended for illustrative purposes only. Variations of the light therapydevice 100 are within the scope of this disclosure for otherapplications of light therapy to a body organ. A body organ can comprisean entirety of a body structure (such as a hand, leg, head, scalp,etc.). In addition, the body organ can comprise skin or tissue that ispart of such a body structure.

A dome 102 is configured with a plurality of ferrule openings 110 and aplurality of holes 120 for a plurality of optical fiber or illuminationassemblies 200, only one of which is shown for clarity, extendingbetween an interior surface 104 to an exterior surface 106 of the dome100. As noted herein, the illumination source can comprise an opticalfiber having a source of illumination at the end of the fiber closest tothe tissue. Alternatively, or in combination, the devices can includeone or more projection elements, where each projection element comprisesa distal portion having an illumination source configured to direct theelectromagnetic energy to the body organ.

The ferrule openings 110 are configured with a taper from the interiorsurface 104 to the exterior surface 104 adapted to operably connect atapered end 222 of a base 220 therein as shown in FIG. 3. The pluralityof holes 120 are located adjacent to a ferrule opening 110 andconfigured in a dimension to be spaced apart such that the light from aplurality of optical illumination assemblies 2000 disposed in theferrule opening 110 and holes 120 provide sufficient light therapycoverage over a treatment area and/or surface of the body organ in asubstantially uniform manner. The optical fibers assemblies orillumination assemblies are independently biased so that the tips 216 ofthe optical fibers/projection elements 210 of each assembly can betterconform to the shape of the head and/or be operably in contact with thebody organ. This independent biasing allows for an improved device withmultiple illumination sources that achieve a perpendicular approach tothe target tissue. The independent biasing allows each assembly toconform to a contoured surface of the body organ without significantlyaffecting adjacent assemblies, which increases the ability of theadjacent assemblies to irradiate the tissue in a normal direction.Lambert's cosine law predicts that an illumination beam that isperpendicular to its target can achieve a higher rate of irradiance. Incontrast, a beam that is offset from a perpendicular approach will havea greater degree of reflection off of the target area. Which means thata curved or contoured surface like the scalp (or any other contouredbody organ) has a greater chance of being irradiated if the sources ofillumination irradiate the scalp at a perpendicular angle. Theindependent biasing of the plurality of illumination assemblies candecrease the overall reflectance of light from a curved surface andincrease the effectiveness or uniformity of the LLLT applied.

The optical fibers/projection elements 210 are associated and opticallycoupled to a light source 310 situated above the dome 102.Advantageously, light therapy device 100 may dissipate any heatgenerated by a plurality of the light sources 310 to be located awayfrom the body organ, i.e. the skin of a patient's scalp such as, forexample, the heat is dissipated through vents 410, 510 as shown in FIGS.5 and 6. Optionally, a cooling source 402 can be fluidly coupled to thedevice to cool any component within the device and/or tissue.

Referring to FIGS. 1-4, the light therapy device 100 may be formedhaving the light sources 310 disposed on a flexible printed circuitboard (flex PCB) 300. The flex PCB 300 is configured to be locatedadjacent the dome 102 and wrapped at a predetermined offset distanceand/or gap 202 around the dome 102, as shown in FIG. 2. Thepredetermined offset distance and/or gap 202 is configured by thedimension of the fiber/illumination assembly 200. The flex PCB 300 maybe formed of suitable materials and/or construction that allows bendingin a direction parallel to, and flexing in a direction normal to, thesurface of the dome 102. The flex PCB 300 is configured with anelectronic circuit to energize the light sources 310.

FIG. 3 illustrates the link from light source to skin achieved by thelight therapy device 100. The optical fibers/projection elements 210 arecoupled to the light source 310 by means of an opticalfiber/illumination assembly 200. The optical fiber/illumination assembly200 is attached at one end to the dome 102 and at the other end adjacentto the light sources 310 operably connected by the electrical circuit inthe flex PCB 300. For example, one or more slots 320 may be formed inthe flex PCB 300 configured to engage one or more locking posts 236 ofthe ferrule 230 as shown in FIGS. 1-3. In this manner, the opticalfiber/illumination assembly 200 may be located adjacent to the lightsources 310 thereby optically connecting so as to transmit light alongthe optical fibers/projection elements 210, 212 to the body organ.

According to an embodiment of the light therapy device 100, as isillustrated in FIGS. 1-3. For convenience, the variations are discussedas having an optical fiber. However, a projection element with anillumination source can be used in place of or in addition to theoptical fiber assembly or fiber itself.

In FIGS. 1-3, the optical fiber assembly 200 comprises a base 220, aferrule 230, a spring 240, a fiber collar 250, and one or more opticalfibers 210. The base 220 may be configured with a base tube 224 alongits longitudinal length, a tapered end 222 to be received in the dome102, and a projecting proximal end 223 with a guide shaft 225 adapted toreceive an inner tube 232 of the ferrule 230 therein. The ferrule 230also may be configured with ferrule tube 234 along its longitudinallength for passing an axial optical fiber 212 there-through, wherebythis centrally located, axial optical fiber 212 is allowed to movewithin the openings 224, 234 (e.g. to travel up and down) by means ofaligning the pair of concentric base and ferrule tubes 224, 234 formedin the base 220 and ferrule 230. The other optical fibers 210 may beconnected at one end in one or more fiber holes 238 formed in a baseportion 232 of the ferrule 230 and, at points along the optical fibers210, by a fiber collar 250, whereby these optical fibers 210 are fixedto the ferrule 230 in the base portion 232, are aligned with and passthrough the plurality of fiber openings 220 in the dome 102 so as toslide freely there-through. Consequently, the free ends 216 of theoptical fibers 210 and axial optical fiber 212 are configured tooperatively connect to the body organ. Additionally, the base 220 andferrule 230 are connected to each other by means of a biasing element240 (e.g. a spring) that functions to provide a force to fiber opticalassembly 200 so as to gently push the free ends 216 of each opticalfibers 210, 212 into contact with the scalp. Accordingly, the lighttherapy device 100 advantageously provides light in direct contact withthe body organ so as to guide light for light therapy directly from thelight source 310 to the scalp or skin.

As shown in FIG. 3, the ferrule 230 is assembled to the base 224 bymeans of a spring 240 configured to be received in recesses 270 formedin the base and ferrule, whereby the spring 240 may snap-fit into therecesses 270 for ease of assembly. Once assembled, the spring 240 isconfigured to provide sufficient retention force on the recesses 270such that the spring 240 remains attached and the biasing force allowsthe inner tube 232 of ferrule 230 to move in the guide shaft 225 of thebase 220 during extension, for example, when connecting directly to thecontour of the body organ that forces free ends 216 of the opticalfibers 210, 212 away from the body organ. The base 224 comprises atapered end 222, which is press fit into a tapered hole 110 extendingbetween the interior and exterior surfaces 104, 106 formed in the dome102. The spring 240 locks the proximal end 223 of the base 220 above thedome 102 thereby preventing the base 220 from disengaging or otherwisefalling out of the tapered hole 110. The inner tube 232 is configured toslide into the guide shaft 225 of the base 220 thereby providing passivealignment of the axial optical fiber 212 relative to the tapered hole110 in the dome 102. Similarly, the fiber collar 250 is configured tosecure and/or align the optical fibers 210 in a precise array such thatthe optical fibers 210 may be inserted insert into, and move freelywithin, the fiber holes 120 formed in the dome 102.

As is illustrated in FIG. 3, the ferrule 230 is aligned to the lightsource 310 by means of slots 320 in the flex PCB 300. The slots 336engage locking posts 236 disposed on a top end of a body portion 234 ofthe ferrule 230. The posts 236 are configured to engage the slots 336positioned in a circular array such that, once engaged, the posts 236may rotate within the slots 336 while keeping the ferrule 230 centeredwith respect to the light source 310. The fiber assembly 200 isadjustable as the posts 236 and slots 336 also are configured to providefor rotational alignment of the circular array of optical fibers 210 tothe fiber holes 120 formed in the dome 102, as shown in FIG. 3.

Referring to FIGS. 1-3, the body portion 232 of the ferrule 230comprises multiple fiber holes 238 which align the optical fibers 210 tothe light source 310. In this embodiment, seven fibers are aligned to alight emitting diode (LED) 310: one axial optical fiber 212 along alengthwise, longitudinal and/or vertical axis of the ferrule 230 and sixoptical fibers 210 arranged in a circular array 214 at an angle to thevertical axis sufficient to effectuate fiber-coupled light. At theproximal end each of the seven fibers, specifically, the optical fibers210 and the axial optical fiber 212 are configured to capture asignificant fraction of the optical power emitted by the light source310. Furthermore, the positioning of the optical fibers 210 in the baseportion 214 and the axial optical fiber 212 in the base tube 224 andferrule tube 234 is such that the fiber-coupled light is substantiallyevenly distributed amongst the seven fibers. The axial optical fiber 212is secured within a hole formed by the base tube 224 and the ferule tube234 in the center of the ferrule 230, thereby remaining parallel to theaxis of motion. Each optical fiber 210 in the circular fiber array 214is bent by means of a fiber collar 250 such that the free distal end 216is substantially parallel to the axial optical fiber 212. In this way,all seven fibers 210, 212 may travel freely in a direction parallel tothe axis of the ferrule 230 that is arranged substantially normal to thesurface of the dome 102.

As shown in FIG. 1, the light therapy device 100 consists of matching acircular array 214 of optical fibers 120 to any hole array 228 of thefiber holes 120 surrounding the tapered hole 110 in the dome 102. Thecircular fiber array 214 penetrates the matching hole array 228 suchthat all seven fibers 210, 212 travel simultaneously. As shown in FIGS.2 and 3, the light therapy device 100 may be configured to limit fibertravel in a dimension in extent toward the distal end 216 by the matingof the concentric base 228 and ferrule tubes 234 formed in the base 220and ferrule 230 (maximum fiber length below the dome 102), and at theproximal end 223 by the interior surface 104 of the dome 102 (fiber tips216 flush with the dome 102). The tips 216 of the optical fibers 120 andaxial optical fiber 212 may be shaped for patient comfort. The shape ofthe fiber tips 216 can also be configured to spread the light laterallyto an area larger than the fiber diameter.

For example, as shown in FIG. 2, when a patient's head is placed withinthe dome 102 adjacent the inner surface 104 the scalp engages theextending fibers 120 and axial optical fiber 212 and pushes theseradially outward, with each fiber array 214 flexing individually in aparticular hole array 228 depending on the particular shape of thescalp. In this way, the fiber arrays 214 of the light therapy device 100can conformally and simultaneously contact the entirety of the scalp.The optical fibers 120 and the axial optical fiber 212 are configuredflexible to allow bending to accommodate a shift of position of thescalp with respect to the interior surface 104 of the dome 102, forexample, bending slightly off-axis when moved on the scalp.Consequently, the light therapy device 100 may be integrated into aportable, wearable helmet as shown in FIG. 5.

FIG. 4 displays one section of the flex PCB 300 in position above thedome 102 and prior to assembly. In an exemplary embodiment, the flex PCB300 comprises a thin, flexible material that is cut in lines of reliefto bend and/or to conform to the shape of the dome 102.

The dome 102 is affixed to a base 400, as illustrated in FIG. 5. Thebase contains a rigid PCB (not shown), which contains the controlelectronics. The flexible PCB containing the light sources is connectedto the rigid PCB. The base can also contain one or more batteries (alsonot shown) which are capable of powering the device for the duration ofthe treatment. An outer shell 500, which may itself be either flexibleor rigid, protects the flex PCB 300 and other elements of the lighttherapy device 100 from physical and other interference. The heat fromthe light sources and associated control electronics are dissipated bymeans of vents in the base 410 and outer shell 510, which draw cool airin from the bottom and allow heated air to escape from the top.

Referring to FIGS. 6 through 8, another embodiment of a light therapydevice 100 provides direct contact between the body organ and theoptical fiber 120 using an alternative design. The light therapy device100 comprises a ferrule 235, an array of light sources 310 andassociated control electronics (not shown) mounted on a rigid PCB 330that may be secured to the base 400 at the back of the dome 102. Thedome 102 similarly contains tapered holes 110 formed by the openingextending between an interior surface 104 and an exterior surface 106.The tapered holes 110 are configured to receive a plurality of opticalfiber assemblies 200, only one of which is shown in FIG. 6. Axialoptical fibers 212 disposed in the ferrule 235 are configured so thatthe tips 216 of the axial optical fibers 212 conform to the shape of thehead and/or body organ. The axial optical fibers 212 are coupled to thelight sources 310 at the back of the dome 102 by means of an adapter630. The adapter 630 may be configured to fasten and secure to a rigidprinted circuit board (PCB) 330 by interlocking tabs of a leaf springlatch 620 in a notch formed in the adapter 630 as shown in FIG. 8. Therigid PCB 330 is configured with the electrical circuit for the lightsources 310 and control electronics. A source of electrical power may beconfigured into the rigid PCB 300 assembly such as, for example,batteries (not shown). The source of electrical power is configuredcapable of powering the light therapy device 100 for the duration of thetreatment.

As shown in FIGS. 6 and 7. the dome 102 is affixed to a base 400 and anouter shell 500. The heat from the light sources 310 and associateddriver electronics are mitigated by means of one or more vents 410 and510 in the helmet. These one or more vents 410 in the helmet base, asshown in FIG. 5 are configured to draw cool air in, while vents 510 inthe helmet top allow heated air to escape. The helmet may be formed withan outer shell configured in the helmet base and helmet top portions.The outer shell may be formed flexible and/or rigid, as well as formedto protect the flex PCB 300 and other elements of the light therapydevice 100 from physical and other interference.

As is illustrated in FIG. 7, the light therapy device 100 comprises anoptical fiber assembly 200 attached using tapered holes 212 in the dome102. The fiber assembly comprises a base 220, a ferrule 235, a flangeguide 237, a spring 240 and one or more optical axial optical fibers212. The ferrule 235 comprises a bent tube 238 formed in the flangeguide 237 that directs the axial optical fiber 212 toward the rear ofthe dome 102 for connecting to the rigid PCB 300 using the adapter 600.The movement or action of the axial optical fiber 212 can be achieved bymeans of inner 232 and outer 220 tubes formed by the base 222 andferrule 235 which slide concentrically with respect to each other. Theinner 232 and outer 220 tubes are biased by means of a biasing element240, e.g. a spring. The light therapy device 100 may be configured witha biasing force selected so that an aggregate spring force of alloptical fiber assemblies 200 allow all axial optical fibers 212 to makecontact with the scalp simultaneously.

As shown in FIGS. 6-8, the ferrule 235 is attached to the dome 102 bymeans of a tapered base 222 and is configured to operably connect to thetapered holes 110. The tapered base 222 comprises slight protrusions 226configured to slidably, snap fit to a recesses 112 in the tapered holes110, thereby allowing rotation, and preventing the tapered base 222 fromdislodging and/or otherwise falling out. The ferrule 230 is secured tothe tapered base 222 by means of a spring 240 configured to slidably,snap fit into a recess 270 a configured in the tapered base 222 and arecess 270 b formed in the ferrule 235. Once assembled, the biasingelement 240 (e.g. spring) is configured to have sufficient retentionforce on the recesses 270 a, 270 b such that it remains attached at eachend during extension.

As shown in FIG. 8, the light therapy device 100 comprises one or morearrays of light sources 310 and their control electronics (not shown)mounted on a rigid PCB 330, which is secured to the base 400 at the backof the dome 102. A multi-fiber ferrule (MFF) 600 can be configured toalign the light sources 310 to each axial optical fiber 212 disposed inone or more fiber openings or an array of fiber holes 610 by means of anadapter 630 secured to the rigid PCB 330. The adapter 630 may beconfigured to align the one or more fiber openings 610 over arrays lightsources 310 (e.g. rows of individual light sources 310) and fiberopenings 610. The adapter 630 may connect to align the ends of each ofthe axial optical fibers 212 disposed in fiber openings 610 adjacent tothe light source arrays 310 by means of precision screw holes 340 in thePCB. The MFF 600 comprises the array of fiber holes 610 populated byreceiving a plurality of axial optical fibers 212 herein. The MFF 600 issecured to the adapter 630 by leaf spring latches 620. Advantageously,the latches 620 may act as leaf springs to center the MFF 600 within theadapter 630, thereby providing fine alignment of the fiber openings 610adjacent to the light sources 310.

The devices and methods described herein can optimize cell proliferation(i.e. growth of hair) with low doses over longer periods of time. It isbelieved that LLLT/PBM creates a dose dependent effect so each dosebuilds on the previous treatment (and the Arndt-Schulz Law means thattoo much dose has suppressive effects). Therefore, the assembliesdisclosed herein allow for a uniform treatment applied in a manner thatavoids the suppressive effects of over-treatment. In one example, it wasfound that 14-20 minutes applied every few days was sufficient topenetrate to the depth of the hair follicle within the skin.

The previous description of the disclosed embodiments is provided toenable any person skilled in the art to make or use the presentinvention. Various modifications to these embodiments will be readilyapparent to those skilled in the art, and the generic principles definedherein can be applied to other embodiments without departing from thespirit or scope of the invention. For example, a wide variety ofmaterials may be chosen for the various components of the embodiments.It is therefore desired that the present embodiments be considered inall respects as illustrative and not restrictive, reference being madeto the appended claims as well as the foregoing descriptions to indicatethe scope of the invention.

1. A device for positioning over and applying electromagnetic energy toa body organ, the device comprising: a support structure forming acontoured shape, where an interior space of the contoured shape isadapted for placement over the body organ; a dome structure locatedwithin the interior space of the contoured shape and spaced from thesupport structure, the dome structure comprising a plurality ofopenings; a plurality of projection assemblies each having at least oneprojection element, where each projection element comprises a proximalportion and a distal portion, the proximal portion configured to receiveelectromagnetic energy from an illumination source, the distal portionconfigured to direct the electromagnetic energy to the body organ, andthe distal portion having a dimension to be received in at least one ofthe plurality of openings; and a biasing element located between thedome structure and the support structure, the biasing element configuredto move the proximal portion of at least one of the plurality ofprojection assemblies relative to the dome structure that causes thedistal portion of the projection element to extend through at least oneof the plurality of openings into the interior space of the contouredshape, where the biasing element permits movement of the projectionelement upon engaging a surface of the body organ to independentlyconform to the body organ and permitting the illumination source toremain adjacent to the surface of the body organ.
 2. The device of claim1, where each of the plurality of projection assemblies comprise acentral projection element and at least one auxiliary projection elementlocated adjacent to the central projection element
 3. The device ofclaim 2, where the central projection element is surrounded by at leasttwo auxiliary projection elements.
 4. The device of claim 1, where theillumination source comprises a source of electromagnetic energy on theproximal portion of the projection element configured to transmitelectromagnetic energy therein to the distal portion.
 5. The device ofclaim 1, where the distal end of the projection element is atraumaticsuch that it does not penetrate the surface of the body organ.
 6. Thedevice of claim 1, where the projection element comprises an opticalguide configured to direct the electromagnetic energy to the body organ.7. The device of claim 1, where the illumination source comprises alight emitting diode.
 8. The device of claim 1, further comprising atleast one cooling mechanism coupled to the support structure.